510(k) K011928

HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 by Northgate Technologies, Inc. — Product Code FPA

K011928 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.